RANDOMIZED, PROSPECTIVE TRIAL OF FENOLDOPAM VS SODIUM-NITROPRUSSIDE IN THE TREATMENT OF ACUTE SEVERE HYPERTENSION

Objective: To compare the safeties and efficacies of IV fenoldopam (FN P) vs sodium nitroprusside (NTP) in severe acute hypertension. Methods : A prospective, randomized, open-label, multicenter international tri al, at 24 academic medical centers, was conducted. The participants we re adult patients (21-80 years of age) who had supine diastolic blood pressures (DBPs) greater than or equal to 120 mm Hg, were capable of w ritten informed consent, and did not have selected exclusion criteria. The subjects were randomized to either FNP or NTP therapy; DBP was ti trated to 95-110 mm Hg, or a maximum reduction of 40 mm Hg for very hi gh pressures. Infusions were maintained for at least six hours, then t he patients were weaned off the IV therapy and oral medication was sta rted. Measurements included BP, heart rate, and duration of study drug infusion and frequency of side effects or complications. Results: A t otal of 183 patients (90 FNP, 93 NTP) were enrolled. Fifteen patients from each arm were excluded from efficacy analysis due to protocol vio lation. There was no significant difference in baseline characteristic s. The two antihypertensive agents were equivalent in controlling and maintaining DBP. Systolic blood pressure (SEP) was reduced to a slight ly greater degree for the NTP-treated patients during the initial (0.5 -1-hr) study period, and both SEP and DBP were reduced more for the FN P-treated patients in the subset receiving infusions during the 12-24- hour period. The adverse effect profiles of the drugs were similar, as were the times to achieve target pressure, with no clinically relevan t difference. Conclusions: For patients who had acute severe hypertens ion, FNP and NTP were equivalent in terms of efficacy and acute advers e events. Because of a unique mechanism of action, FNP may have advant ages in selected subsets of patients. Further studies may be indicated in patient populations with pure ''hypertensive emergencies.''